The following Background of the Invention is intended to aid the reader in understanding the invention and is not admitted to be prior art.
The inclusion of positive and negative control tests in the performance of an assay is an important component for verifying the validity of the results of any assay. A variety of methods have been used to introduce and include control testing in various assay format. For example, control tests have been included in immunological test formats by utilizing a control zone where analyte is bound to a control line in the assay. Thus, a colored line appears when a labeled control reagent is bound at the control line. These and other types of control tests are effective for verifying that the assay device is functioning correctly, but they also result in added expense and inefficiency in manufacturing the devices and performing the assays, particularly when the specific binding molecules used in the control test are produced as a result of elaborate procedures. Additionally, these types of controls can be confusing for the untrained general consumer and lead to improper test interpretation. There is therefore a need for better and more efficient devices and methods for performing sample testing.